Breakthrough Clinical Results
EmpNia Inc. announced FDA clearance for its eMotus™ system, a disposable sensor pad and software for managing respiratory motion in image-guided radiation therapy (IGRT). eMotus addresses challenges with existing solutions by offering a simple, universal, and cost-effective approach. The system is designed for easy setup and use across various patient types and imaging/therapy modalities, eliminating the need for costly infrastructure investments. Pre-market evaluations showed significant improvements in workflow efficiency, setup simplicity, and motion tracking accuracy.
Key Highlights
- FDA clearance granted for eMotus™ respiratory motion management system.
- eMotus™ offers a simple, universal, and cost-effective solution for IGRT.
- System features a disposable sensor pad and intuitive software for easy setup and use.
- Pre-market evaluations demonstrated significant improvements in workflow and accuracy.
Incidence and Prevalence
Global Epidemiological Data on Image-Guided Radiation Therapy (IGRT)
Based on the available information, there are significant limitations in the current data regarding Image-guided radiation therapy (IGRT) epidemiology and implementation:
- No specific information is available about Image-guided radiation therapy (IGRT) epidemiological metrics
- The data lacks global incidence rates, prevalence statistics, or utilization patterns of IGRT
- While information exists on radiation therapy and imaging techniques in general, none specifically addresses IGRT epidemiological metrics
- No data is provided regarding the worldwide adoption and implementation status of IGRT technologies such as cone-beam computed tomography (CBCT), ultrasound guidance, or fiducial marker tracking
The available information covers other topics such as non-ionizing radiation, quantitative imaging biomarkers, PET imaging, radioprotective agents, and contrast-induced nephropathy, but does not include IGRT utilization patterns or implementation status.
Based on the provided abstracts, there isn't specific mention of key unmet needs and target populations for Image-guided radiation therapy (IGRT) within the last 3 years. However, the abstracts do discuss unmet needs and targeted therapies in several disease areas, including:
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Cancer:
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A need for tailored therapies for individual cancer patients due to varying responses to targeted therapies based on unique genomic profiles. Next-generation sequencing is highlighted as a key technology for identifying actionable targets.
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Standardization of clinical trial design for patients with HER2-positive metastatic breast cancer and brain metastases is needed to improve treatment access and interpretation of treatment landscape.
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Drug-resistant epilepsy (DRE) represents a significant unmet need, requiring improved efficacy and safety profiles of anti-seizure medications (ASMs), specific treatment protocols, and earlier diagnosis.
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Triple-negative breast cancer (TNBC) requires new therapeutic strategies due to its aggressive nature and high relapse rates. Research suggests K-RAS/SIAH pathway activation as a potential drug target.
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Autoimmune and Inflammatory Diseases:
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Rheumatoid arthritis (RA): Next-generation bDMARDs and expanded indications for existing therapies are anticipated. Adequate screening and monitoring for patients treated with JAK inhibitors is crucial.
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Chronic urticaria: A personalized, endotype-based approach is emerging due to the heterogeneous nature of the disease. Promising new treatments include Bruton's tyrosine kinase inhibitors, anti-cytokine therapies, and mast cell depletion.
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Type 2 chronic inflammatory diseases (atopic dermatitis, chronic prurigo, chronic urticaria, asthma, chronic rhinosinusitis with nasal polyps): A high need for targeted therapies exists. Epithelial barrier defects and dysbiotic microbiomes represent exciting future drug targets.
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Systemic lupus erythematosus (SLE): New approaches are needed for fatigue management. New biologics targeting B cells, T cells, or cytokines are under investigation for refractory SLE.
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Psoriasis: Research is focused on identifying additional effector cells, mediators, and trigger factors to develop next-generation targeted therapies and address comorbidities.
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Other Conditions:
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Substance use disorder (SUD): Few reproductive-age women who need SUD treatment receive it. Racial disparities in access exist, and gender-informed services need expansion.
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Food allergy: The traditional paradigm of avoidance and emergency medication is shifting. Ongoing clinical trials are exploring new treatment approaches, and optimized trial designs are needed.
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Rehabilitation services: A global demand for rehabilitation services exists, with significant unmet needs due to limited service provision, geographical distribution issues, transportation barriers, and cost.
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Unmet health-related social needs: Care delivery models that address these needs through screening, referral, and tracking are being explored, but further research is needed to determine their overall impact.
To find specific information on IGRT, it would be necessary to conduct a targeted search within PubMed using relevant keywords such as "image-guided radiation therapy", combined with specific disease areas or populations of interest.
Drug used in other indications
Information on eMotus™ Clinical Applications
After careful review of all available information, there is no data present regarding eMotus™ or its clinical trials for Image-guided radiation therapy (IGRT) or any other therapeutic indications. The information sources do not contain any references to:
- Clinical indications for eMotus™ beyond IGRT
- Intervention models or methodologies for eMotus™ trials
- Treatment protocols or clinical trial designs for the eMotus™ system
- Preliminary efficacy outcomes or safety profiles for eMotus™ in any therapeutic context
- Applications of eMotus™ outside of radiation oncology
No information about the eMotus™ motion management system appears in the provided context.